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Description of Business and Summary of Significant Accounting Policies (Policies) | 9 Months Ended
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Sep. 30, 2020
Accounting Policies [Abstract] |
Organization and Nature of Operations | (a) Organization and Nature of Operations Biodesix, Inc. (the “Company”), formerly Elston Technologies, Inc., was incorporated in Delaware in 2005. The Company’s headquarters are in Colorado, with laboratories in Colorado, Kansas, and Washington. Biodesix is a data-driven diagnostic solutions company leveraging state of the art technologies with its proprietary artificial intelligence platform to discover, develop, and commercialize solutions for clinical unmet needs, with a primary focus in lung disease. In addition to diagnostic tests, the Company provides biopharmaceutical companies with services that include diagnostic research, clinical trial testing, and the discovery, development, and commercialization of companion diagnostics. In March 2020, the World Health Organization declared the outbreak of COVID-19, a novel strain of coronavirus, a global pandemic. This outbreak is causing major disruptions to businesses and markets worldwide as the virus spreads. The COVID-19 pandemic has disrupted, and the Company expects will continue to disrupt, its operations. In addition, the COVID-19 pandemic also has started to negatively affect, and the Company expects will continue to negatively affect, its non-COVID-19 testing-related revenue and its clinical studies. The extent of the effect on the Company’s operational and financial performance will depend on future developments, including the duration, spread and intensity of the pandemic, and governmental, regulatory and private sector responses, all of which are uncertain and difficult to predict. Although the Company is unable to estimate the financial effect of the pandemic, at this time, if the pandemic continues over a long period of time, it could have a material adverse effect on the Company’s business, results of operations, financial condition, and cash flows. The condensed financial statements do not reflect any adjustments as a result of the pandemic. As of September 30, 2020, the Company has cash and cash equivalents of $6.3 million, accumulated deficit of $257.7 million, and stockholders’ deficit as of $255.2 million. The Company may seek additional funding through private or public equity financings, collaborations, strategic alliances and marketing, distribution or licensing agreements. If the Company is unable to obtain additional funding, the Company will be forced to delay, reduce or eliminate some or all if its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all. The Company believes that it has sufficient cash and cash equivalents, after considering the proceeds from its initial public offering of $63.0 million in October 2020, to fund its operations at least through twelve months following the issuance of these financial statements. The Company is subject to various risks and uncertainties frequently encountered by early stage life science companies. Such risks and uncertainties include, but are not limited to, undeveloped technology, strict regulatory requirements and approval of products, a limited operating history, competition from other service providers, dependence on key personnel, the need for ongoing capital to fund operations, and management of rapid growth. To address these risks, the Company must, among other things, successfully develop its customer base, successfully execute its business and marketing strategy, successfully develop its technology, raise capital on acceptable terms to the Company, and attract, retain, and motivate qualified personnel. There can be no guarantee that the Company will be successful in addressing these or other such risks.
Basis of Presentation | (b) Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the instructions of the Securities and Exchange Commission (“SEC”) on Form 10-Q and Rule 10-01 of Regulation S-X. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been omitted. The accompanying unaudited condensed financial statements include all known adjustments necessary for a fair presentation of the results of interim periods as required by GAAP. These adjustments consist primarily of normal recurring accruals and estimates that impact the carrying value of assets and liabilities. Operating results for the period ended September 30, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2020. Management performed an evaluation of the Company’s activities through the date of the filing of this Quarterly Report on Form 10-Q. The accompanying unaudited condensed financial statements should be read in conjunction with the audited financial statements and the related notes for the year ended December 31, 2019, which are included in the Company’s final prospectus filed with the SEC pursuant to Rule 424(b)(4) on October 29, 2020 under the Securities Act of 1933, as amended (the “Securities Act”).
Reverse Stock Split and Initial Public Offering | (c) Reverse Stock Split and Initial Public Offering O n October 19, 2020, the Company obtained approval of an amended and restated certificate of incorporation effecting a 0.1684664-for-1 reverse stock split of its issued and outstanding common stock as converted. All common shares, stock options, and per share information presented in these financial statements and notes thereto have been adjusted, where applicable, to reflect the reverse stock split on a retroactive basis for all periods presented. The per share par value and authorized number of shares of the Company’s common stock were not adjusted as a result of the reverse stock split. The Company’s registration statement on Form S-1 related to its initial public offering (“IPO”) was declared effective by the SEC on October 27, 2020, and the Company’s common stock began trading on the Nasdaq Global Market on October 28, 2020. On October 30, 2020, the Company closed its IPO, in which the Company issued and sold 4,000,000 shares of its common stock, at a price to the public of $18.00 per share. The Company received approximately $63.0 million in net proceeds, after deducting underwriting discounts and commissions and other offering expenses payable by the Company. In connection with the IPO, all outstanding shares of the Company’s convertible preferred stock and convertible notes payable converted into 21,939,025 shares of common stock. The unaudited condensed financial statements, including share and per share amounts, do not give effect to the IPO or the related conversion of securities into shares of common stock. In addition, the put option liability related to the convertible notes payable was transferred to additional paid-in capital upon the closing of the IPO.
Use of Estimates | (d) Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Areas of the financial statements where estimates have the most significant effect include the valuation of contingent consideration and purchased technology related to the Company’s business acquisition, valuation of impairment of goodwill and long-lived assets, stock-based compensation, valuation of put option liabilities, and the valuation allowance related to net deferred tax assets. Actual results could differ from those estimates.
Segment Information | (e) Segment Information The Company operates in one operating segment and, accordingly, no segment disclosures have been presented herein. All equipment, leasehold improvements, and other fixed assets are physically located within the United States.
Comprehensive Loss | (f) Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. If the Company had comprehensive gains (losses), they would be reflected in the statement of operations and comprehensive loss and as a separate component in the statement of stockholders’ deficit. There were no elements of comprehensive loss during the nine months ended September 30, 2020 and 2019.
Concentration of Risk | (g) Concentration of Risk The Company is subject to credit risk from its accounts receivable related to services provided to its customers. Reimbursement on behalf of customers covered by Medicare accounted for 61% and 58% of the Company’s non-COVID-19 diagnostic test revenue for the nine months ended September 30, 2020 and 2019, respectively and represented 17% and 18% of the Company’s total accounts receivable as of September 30, 2020 and December 31, 2019, respectively. One services customer represented 10% and 44% of the Company’s total accounts receivable balance as of September 30, 2020 and December 31, 2019, respectively. Two diagnostic test customers represented 35% and 0% of the Company’s total accounts receivable balance as of September 30, 2020 and December 31, 2019, respectively.
Cash, Cash Equivalents, and Restricted Cash | (h) Cash, Cash Equivalents, and Restricted Cash The Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. The Company continually monitors its positions with, and the credit quality of, the financial institutions with which it invests. Periodically throughout the year, the Company has maintained balances in various operating accounts in excess of federally insured limits. Included in cash and cash equivalents are money market funds recorded at $4.8 million at September 30, 2020 and December 31, 2019. These money market funds were measured using Level 1 inputs. Restricted cash consists of deposits related to the Company’s corporate credit card and a letter of credit related to an operating lease agreement. As of September 30, 2020 and December 31, 2019, the Company had $0.2 million in restricted cash, which was included in other current assets in the accompanying balance sheets. The majority of the Company’s cash and cash equivalents are deposited with one major financial institution in the United States. Deposits with this institution may exceed the amount of insurance provided on such deposits. The Company has not experienced any losses on its deposits of cash and cash equivalents.
Accounts Receivable | (i) Accounts Receivable The Company provides an allowance for doubtful accounts based on experience and specifically identified risks. Accounts receivable are recorded at carrying value and charged off against the allowance for doubtful accounts when it is determined that recovery is unlikely and cease collection efforts cease. The Company analyzes trade accounts receivable quarterly and considers historic experience, customer creditworthiness, facts and circumstances specific to outstanding balances, and payment terms when evaluating the adequacy of the allowance for doubtful accounts. The Company recorded an allowance for doubtful accounts of $0.2 million as of September 30, 2020 and December 31, 2019, respectively.
Inventory | (j) Inventory Inventories are stated at the lower of cost or net realizable value on a first-in, first-out basis. Inventory consists primarily of supplies, which are consumed when processing tests. The Company does not maintain any finished goods inventory. Inventory balances were $3.2 million and $0.8 million as of September 30, 2020 and December 31, 2019, respectively, and are included in other current assets in the accompanying balance sheets.
Property and Equipment | (k) Property and Equipment Property and equipment are stated at cost. Depreciation is provided utilizing the straight‑line method over the estimated useful lives, ranging from three to five years.
Intangible Assets | (l) Intangible Assets Intangible assets are stated at cost, net of accumulated amortization and include patents, trademarks, and acquired developed technology. Trademarks have an indefinite life and are not being amortized but are reviewed for impairment on an annual basis and more frequently if events or changes in circumstances indicate that it is more likely than not that the assets are impaired. External costs associated with patents are capitalized as long as such efforts are expected to be successful. Upon approval of the patent, the related capitalized costs are amortized over the lesser of the contractual term of the patent or the estimated useful life of 10 years. Acquired developed technology is amortized over a useful life of 9 years. Intangible assets are reviewed for impairment whenever events or changes in circumstances may affect the recoverability of the intangible assets. Such reviews include an analysis of current results and take into consideration the undiscounted value of projected operating cash flows. See Note 2, Business Combinations, for further information.
Long Lived Assets | (m) Long‑Lived Assets The Company reviews its long‑lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recovered. The Company looks primarily to the undiscounted future cash flows in its assessment of whether or not long-lived assets have been impaired. The Company has determined that no impairments are necessary for the periods presented.
Deferred Rent | (n) Deferred Rent The Company leases office space under non‑cancelable, long‑term operating leases that include scheduled increases in minimum rents and renewal provisions at the option of the Company. The expense associated with leases that have escalating payment terms is recognized on a straight‑line basis over the lease term. Tenant improvement allowances received from a lessor are recorded as a deferred rent liability and recognized evenly as a reduction to rent expense over the remaining lease term. The portion of the deferred rent liability that will reverse in the next 12 months is not significant to the balance sheets; therefore, the entire amount was recorded as non‑current in the accompanying condensed financial statements.
Goodwill | (o) Goodwill Goodwill is recorded when the purchase price paid for an acquisition exceeds the estimated fair value of the net identified tangible and intangible assets acquired. Goodwill is not amortized and is tested for impairment at the reporting unit level on an annual basis as of December 31 and between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of the reporting unit below its carrying value. The Company may first perform a qualitative assessment to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying value. If it is concluded that this is the case, it is necessary to perform a quantitative two-step goodwill impairment test. Otherwise, the two-step goodwill impairment test is not required. The quantitative two-step goodwill impairment review process compares the fair value of the reporting unit in which goodwill resides to its carrying value. Multiple valuation techniques can be used to assess the fair value of the reporting unit. All these techniques include the use of estimates and assumptions that are inherently uncertain. Changes in these estimates and assumptions could materially affect the determination of fair value or goodwill impairment, or both. The Company assessed qualitative factors to determine whether it is more likely than not that the fair value of goodwill exceeded the carrying value. Based on that assessment, there were no events or circumstances in the nine months ended September 30, 2020 and 2019 to indicate that the fair value of goodwill exceeded its carrying value, and thus a quantitative analysis was not performed. The Company did not have any goodwill impairments for the three and nine months ended September 30, 2020 and 2019.
Revenue Recognition | (p) Revenue Recognition Revenue is recognized when control of the promised services is transferred to customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those services. The Company’s revenue is generated from the following:
| • | Diagnostic tests. These services are completed upon the delivery of test results to the prescribing physician, which is considered the performance obligation. The fees for such services are billed either to a third party such as Medicare, medical facilities, commercial insurance payers, or to the patient.
| • | Services. These services are generally completed upon the delivery of test results for assay development and testing services, which is considered the performance obligation. Customers for these services are typically large pharmaceutical companies.
For the three and nine months ended September 30, 2020 and 2019, revenue from these services consisted of the following (in thousands):
|  | Three months ended September 30, |  |  | Nine months ended September 30, |  |
|  | 2020 |  |  | 2019 |  |  | 2020 |  |  | 2019 |  |
Diagnostic tests |  | $ | 8,552 |  |  | $ | 3,770 |  |  | $ | 15,798 |  |  | $ | 12,716 |  |
Services |  |  | 641 |  |  |  | 172 |  |  |  | 2,730 |  |  |  | 3,565 |  |
Total revenue |  | $ | 9,193 |  |  | $ | 3,942 |  |  | $ | 18,528 |  |  | $ | 16,281 |  |
Diagnostic test revenue that were reimbursed by Medicare comprised 63% and 57% of non-COVID-19 diagnostic test revenue for the three months ended September 30, 2020 and 2019, respectively. Diagnostic test revenue that were reimbursed by Medicare comprised 61% and 58% of non-COVID-19 diagnostic test revenue for the nine months ended September 30, 2020 and 2019, respectively. Two services customers comprised 53% and 85% of services revenue for the nine months ended September 30, 2020 and 2019, respectively. For the three and nine months ended September 30, 2020, three health care providers comprised 62% and 42% of diagnostic test revenue, respectively. Revenue from diagnostic tests are recognized when the performance obligation is satisfied, which is when a customer receives results of the Company’s tests, occurring generally upon delivery to the requesting physician. Revenue from services are recognized when the performance obligation is satisfied, which is when a customer receives results of the Company’s tests, occurring generally upon the delivery of test results for assay development and testing services. The Company also provides services to patients with whom the Company does not have contracts as defined in ASC 606, Revenue from Contracts with Customers (ASC 606). The Company recognizes revenue for these patients when contracts as defined in ASC 606 are established at the amount of consideration to which it expects to be entitled or when the Company receives substantially all of the consideration subsequent to the performance obligations being satisfied. The Company determines the transaction price related to its diagnostic test contracts by considering the nature of the payer and historical price concessions granted to groups of customers. For diagnostic test revenue, the Company estimates the transaction price, which is the amount of consideration it expects to be entitled to receive in exchange for providing services based on its historical collection experience, using a portfolio approach as a practical expedient to account for patient contracts as collective groups rather than individually.
Deferred Revenue | (q) Deferred Revenue Deferred revenue has historically primarily consisted of research, development, and testing services fee payments received in advance. As of September 30, 2020, deferred revenue also includes $3.5 million in a Medicare advance payment on testing services which can either be paid back or earned back starting 1 year from receipt.
Research and Development Expenses and Accrued Research and Development Expenses | (r) Research and Development Expenses and Accrued Research and Development Expenses Expenditures made for research and development are charged to expense as incurred. External costs consist primarily payments to clinical trial sites, sample acquisition costs and laboratory supplies purchased in connection with the Company’s discovery and preclinical activities, process development and clinical development activities. Internal costs consist primary of employee-related costs, facilities, depreciation and costs related to compliance with regulatory requirements. The Company estimates and accrues its expenses resulting from its obligations under contracts with vendors and consultants in connection with conducting research and development activities. The financial terms of these contracts vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s estimates depend on the timeliness and accuracy of the data provided by consultants and vendors regarding the status of each activity. The Company periodically evaluates the estimates to determine if adjustments are necessary or appropriate based on information received.
Stock Based Compensation | (s) Stock‑Based Compensation The Company accounts for stock‑based compensation arrangements with employees and recognizes compensation expense for stock‑based awards based on the estimated fair value of the awards. Compensation expense for all employee stock‑based awards is based on the estimated grant‑date fair value and recognized as an expense on a straight-line basis over the requisite service period (generally the vesting period).
Income Taxes | (t) Income Taxes The Company recognizes deferred tax assets and liabilities based on the differences between the tax basis of assets and liabilities and their reported amounts in the financial statements and net operating loss carryforwards that will result in taxable or deductible amounts in future years. The Company establishes a valuation allowance for all deferred tax assets to the extent it is more likely than not that a deferred tax asset will not be realized.
Warrant Liability | (u) Warrant Liability Freestanding financial instruments that permit the holder to acquire shares that are either puttable by the holder, redeemable or contingently redeemable are required to be reported as liabilities in the financial statements. The issuer must present such liabilities on the balance sheets at their estimated fair values. Changes in fair value of the liability are calculated each reporting period, and any change in value is recognized in operations. The Company has determined that certain warrants issued to investors and lenders, which are exercisable for shares of the Company’s convertible preferred stock, shall be classified as liabilities due to a contingent redemption provision.
Changes in Fair Value of Contingent Consideration | (v) Changes in Fair Value of Contingent Consideration In connection with the purchase transaction with Integrated Diagnostics, Inc. (“Indi”), the Company recorded contingent consideration pertaining to the amounts potentially payable to Indi’s shareholder pursuant to the terms of the asset purchase agreement. The fair value of contingent consideration is assessed at each balance sheet date and changes, if any, to the fair value are recognized as operating expenses within the statements of operations. The estimated fair value of the contingent consideration is based upon significant assumptions including probabilities of successful achievement of the related milestone event (“Milestone”), the estimated timing in which the Milestone is achieved, and discount rates. The estimated fair value could materially differ from actual values or fair values determined using different assumptions.
Fair Value of Financial Instruments | (w) Fair Value of Financial Instruments The carrying amounts of financial instruments, including cash and cash equivalents, receivables, other current assets, accounts payable, and accrued liabilities, approximated fair value as of September 30, 2020 and December 31, 2019 because of the relatively short maturity of these instruments. The carrying amounts of long‑term notes payable and convertible notes payable issued approximated fair value as of September 30, 2020 and December 31, 2019 because interest rates on these instruments approximate market interest rates.
Business Combinations | (x) Business Combinations The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination by assessing whether or not the Company has acquired inputs and processes that have the ability to create outputs. If determined to be a business combination, the Company accounts for business acquisitions under the acquisition method of accounting as indicated in the Financial Accounts Standards Board (“FASB”) issued Accounting Standards Codification (“ASC”) Topic 805, Business Combinations (“ASC 805”), which requires the acquiring entity in a business combination to recognize the fair value of all assets acquired and liabilities assumed and establishes the acquisition date as the fair value measurement point. Accordingly, the Company recognizes assets acquired and liabilities assumed in business combinations, including contingent assets and liabilities, and non-controlling interest in the acquiree based on the fair value estimates as of the date of acquisition. In accordance with ASC 805, the Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired.
Deferred Offering Costs | (y) Deferred Offering Costs The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity issuances as deferred offering costs until such equity issuances are consummated. After consummation of the equity issuance, these costs are recorded as a reduction in the capitalized amount associated with the equity issuance. Should the equity issuance be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the unaudited condensed consolidated statement of operations. Upon the IPO closing in October 2020, deferred offering costs were reclassified to additional paid-in capital, representing a reduction in IPO proceeds. As of September 30, 2020 and December 31, 2019, the Company had deferred offering costs of $1.4 million and $0, respectively, which are included in other current assets in the accompanying balance sheets.
Recently Issued Accounting Standards Not Yet Adopted | (z) Recently Issued Accounting Standards Not Yet Adopted In February 2016, the FASB issued ASU No. 2016-02, Leases (ASC Topic 842). The new guidance maintains two classifications of leases: finance leases, which replace capital leases, and operating leases. Lessees will need to recognize a right-of-use asset and a lease liability on the statement of financial position for those leases previously classified as operating leases under the old guidance. The liability will be equal to the present value of lease payments. The asset will be based on the liability, subject to adjustment, such as for direct costs. The accounting standard will be effective for the Company beginning January 1, 2022. The Company is currently evaluating the impact of the lease guidance on the Company’s financial statements.
Net Loss per Share | (aa) Net loss per share Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, the convertible preferred stock, common stock options, restricted stock units, preferred stock warrants and convertible debt are considered to be potentially dilutive securities. Basic and diluted net loss attributable to common stockholders per share is presented in conformity with the two-class method required for participating securities as the convertible preferred stock is considered a participating security. The Company’s participating securities do not have a contractual obligation to share in the Company’s losses. As such, the net loss was attributed entirely to common stockholders. As the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for those periods. The following table sets forth the computation of the basic and diluted net loss per share attributable to common stockholders (in thousands, except per share amounts):
|  | Three months ended September 30, | Nine months ended September 30, |
|  | 2020 |  |  | 2019 |  |  | 2020 |  |  | 2019 |
Numerator |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Net loss attributable to common stockholders |  | $ | (8,845 | ) |  | $ | (9,601 | ) |  | $ | (26,817 | ) |  | $ | (24,201 | )
Denominator |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Weighted-average shares outstanding used in computing net loss per share, basic and diluted |  |  | 277 |  |  |  | 244 |  |  |  | 269 |  |  |  | 233 |
Net loss per share, basic and diluted |  | $ | (31.93 | ) |  | $ | (39.35 | ) |  | $ | (99.69 | ) |  | $ | (103.87 | )
The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been anti-dilutive for the three and nine month periods ended September 30, 2020 and 2019 (in thousands):
|  | Nine months ended September 30, |
|  | 2020 |  |  | 2019 |
Options to purchase common stock |  |  | 2,843 |  |  |  | 2,010 |
Convertible preferred stock |  |  | 119,257 |  |  |  | 119,257 |
Warrants |  |  | 613 |  |  |  | 2,440 |
Restricted stock units |  |  | 79 |  |  |  | 26 |
Convertible debt (1) |  |  | 20,746 |  |  |  | 16,240 |
Total |  |  | 143,538 |  |  |  | 139,973 |
(1) | The number of common shares that convertible debt was assumed to convert to was based on the Company’s estimated common stock price as of September 30, 2020, as determined by the Company’s board of directors (“Board of Directors”) with assistance from a valuation firm.

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